Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017543
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUDIOMIL MAPROTILINE HYDROCHLORIDE 25MG TABLET;ORAL Discontinued None No No
LUDIOMIL MAPROTILINE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None No No
LUDIOMIL MAPROTILINE HYDROCHLORIDE 75MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/01/1980 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/10/1997 SUPPL-30 Labeling

Label is not available on this site.

04/10/1997 SUPPL-29 Labeling

Label is not available on this site.

03/05/1996 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/28/1994 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1997 SUPPL-26 Labeling

Label is not available on this site.

07/12/1993 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1994 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/1990 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/10/1997 SUPPL-21 Labeling

Label is not available on this site.

04/07/1989 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/10/1997 SUPPL-19 Labeling

Label is not available on this site.

04/10/1997 SUPPL-18 Labeling

Label is not available on this site.

03/21/1985 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1985 SUPPL-16 Labeling

Label is not available on this site.

11/04/1983 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1983 SUPPL-14 Labeling

Label is not available on this site.

11/17/1982 SUPPL-12 Labeling

Label is not available on this site.

11/08/1982 SUPPL-11 Labeling

Label is not available on this site.

10/21/1982 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/12/1983 SUPPL-9 Labeling

Label is not available on this site.

08/03/1981 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1981 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1981 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1981 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1981 SUPPL-4 Labeling

Label is not available on this site.

09/30/1982 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/29/1981 SUPPL-1 Efficacy

Label is not available on this site.

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